Golimumab

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Golimumab
Monoclonal antibody
Type Whole antibody
Source Human
Target TNFα
Clinical data
Trade names Simponi
AHFS/Drugs.com Monograph
MedlinePlus a610010
License data
Routes of
administration
Subcutaneous injection
ATC code
Legal status
Legal status
Identifiers
CAS Number
ChemSpider
  • none
UNII
KEGG
ChEMBL
ECHA InfoCard 100.226.360
Chemical and physical data
Formula C6530H10068N1752O2026S44
Molar mass 147 kg/mol
 NYesY (what is this?)  (verify)

Golimumab (CNTO 148)[1] is a human monoclonal antibody which is used as an immunosuppressive drug and marketed under the brand name Simponi. Golimumab targets tumor necrosis factor alpha (TNF-alpha), a pro-inflammatory molecule[2] and hence is a TNF inhibitor.

Golimumab was developed by Janssen Biotech, Inc. (formerly Centocor Biotech, Inc.) which also markets the product in the United States. The Janssen Pharmaceutical Companies market Simponi in Canada, Central and South America, the Middle East, Africa and Asia Pacific. In Europe, Russia and Turkey, Simponi distribution rights are held by Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc. In Japan, Indonesia and Taiwan, distribution rights are held by Mitsubishi Tanabe Pharma Corporation.[3]

Development[edit]

Golimumab binds to both soluble and transmembrane forms of TNFα. The antibody was isolated from a hybridoma clone produced by transgenic mice immunized with human TNFα. The golimumab-secreting clone was selected after being assayed for human light and heavy chains and TNFα-binding. The commercial product is produced in a recombinant cell line cultured by continuous perfusion.[4]

Uses : Approvals and indications[edit]

Golimumab is approved in Canada[5] and the United States[6] as a once monthly subcutaneous treatment for adults with moderately to severely active rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.[7][8]

European Medicines Agency (EMA) has approved the use of golimumab as a treatment for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.[6][not in citation given]

Golimumab was approved for the treatment by the US Food and Drug Administration (FDA) as well as the European Medicines Agency (EMA) in 2013 for the treatment of ulcerative colitis.[9][10]

Clinical trials[edit]

Rheumatoid arthritis[edit]

Large, double-blind randomized controlled trials in patients with rheumatoid arthritis have shown that golimumab in combination with methotrexate was more effective than methotrexate alone.[11]

References[edit]

  1. ^ Mazumdar, Sohini; David Greenwald (2009). "Golimumab". MAbs. 1 (5): 422–431. doi:10.4161/mabs.1.5.9286. 
  2. ^ Statement On A Nonproprietary Name Adopted By The USAN Council – Golimumab, American Medical Association.
  3. ^ "SIMPONI® Receives European Commission Approval For Treatment Of Non-Radiographic Axial Spondyloarthritis | Johnson & Johnson". www.jnj.com. Retrieved 2016-05-09. 
  4. ^ Mazumdar, S; Greenwald, D (2009). "Golimumab". MAbs. 1 (5): 422–431. PMC 2759491Freely accessible. PMID 20065639. 
  5. ^ "Health Canada Approves Simponi (Golimumab) For Treatment Of Rheumatoid Arthritis, Psoriatic Arthritis And Ankylosing Spondylitis". 
  6. ^ a b "Simponi (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis". www.drugs.com. 24 April 2009. Retrieved 2016-05-09. 
  7. ^ "FDA clears potential blockbuster arthritis drug". North County Times. Lee Enterprises. Associated Press. 24 April 2009. Retrieved 23 October 2010. [permanent dead link]
  8. ^ Maxwell, LJ; Zochling, J; Boonen, A; Singh, JA; Veras, MM; Tanjong Ghogomu, E; Benkhalti Jandu, M; Tugwell, P; Wells, GA (18 April 2015). "TNF-alpha inhibitors for ankylosing spondylitis". The Cochrane database of systematic reviews. 4 (4): CD005468. PMID 25887212. doi:10.1002/14651858.CD005468.pub2. 
  9. ^ Löwenberg, Mark; de Boer, Nanne KH; Hoentjen, Frank (2014-03-12). "Golimumab for the treatment of ulcerative colitis". Clinical and Experimental Gastroenterology. 7: 53–59. ISSN 1178-7023. PMC 3958527Freely accessible. PMID 24648749. doi:10.2147/CEG.S48741. 
  10. ^ Johnson & Johnson Reports 2008 First-Quarter Results
  11. ^ Oldfield, Vicki; Plosker, Greg L. (2009). "Golimumab". BioDrugs. 23 (2): 125. PMID 19489653. doi:10.2165/00063030-200923020-00005.